Objective:To observe the clinical efficacy of Shengyang Yiwei Decoction combined with bi smuth in the treatment of Hp positive peptic ulcer(spleen deficiency damp-heat syndr ome),and explore new ideas and methods for the treatment of this disease by combin ing traditional Chinese and Western medicine,for clinical reference.Methods:A randomized controlled trial was conducted to collect 72 patients who met the entry criteria of this study,and then they were randomly divided into an observation group(36patients)and a control group(36 patients).The control group received bismuth quadruple therapy for 2 weeks followed by pantoprazole enteric coated tablets for 4 weeks based on the general practice.The observation group received oral administration of "" Shengyang Yiwei Decoction "" Decoction on the basis of the general treatment and the treatment regimen of the control group.The total treatment duration was 6 weeks in both groups.Four weeks after the end of treatment,the efficacy and safety of the above two treatment regimens were comprehensively evaluated by analyzing and comparing the efficacy of TCM syndromes,the total score of TCM symptoms,the single score of TCM symptoms,the efficacy of gastroscopy,the HP eradication rate,and the incidence of adverse reactions.Result:1.A total of 72 patients were included in this study,6 were dislodged during treatment,and actually a total of 66 completed the clinical study,including 33 in the control group and33 in the observation group.Before treatment,there was no statistical difference between the two groups in terms of gender,age,disease duration,ulcer type,ulcer stage,total score of TCM symptoms,and single score of TCM symptoms(P > 0.05).2.Efficacy of TCM syndromes: after treatment,19 patients in the observation group recovered clinically,5 showed efficacy,6 showed efficacy,and 3 showed no efficacy.In the control group,clinical healing was observed in 10 patients,marked effects in 4 patients,effectiveness in 13 patients,and ineffectiveness in 6 patients,and the efficacy of TCM syndromes in the observation group was better than that of the control group(P < 0.05).3.Total scores of TCM symptoms: after treatment,the total scores of TCM symptoms in both groups were significantly lower compared with those before treatment(P < 0.05),and the total scores of TCM symptoms in the observation group were significantly lower than those in the control group(P < 0.05).4.TCM single item symptom scores: after treatment,the scores of each TCM single item symptom in both groups were significantly decreased compared with those before treatment(P < 0.05),and the observation group was superior(P < 0.05)to the control group in improving epigastric pain,epigastric distension,limb burnout,little Qi sloth speech,mouth ache or soreness,and short and yellow stools symptoms,but equivalent(P > 0.05)in improving eating little / nanosight symptoms.5.Hp eradication rate: after treatment,29 cases of Hp eradication and 4 cases of non eradication were observed in the observation group.In the control group,HP was eradicated in 26 cases and not eradicated in 7 cases,and the HP eradication rate was 87.9% in the observation group.The eradication rate of Hp in the control group was 78.8%,with no significant difference between the two groups(P > 0.05).6.Gastroscopic efficacy: after treatment,23 patients in the observation group recovered clinically,7 showed efficacy,2 effective,and 1 ineffective.In the control group,17 patients were clinically healed,4 showed efficacy,8 were effective and 4 were ineffective,and the healing of ulcers under gastroscopy was better in the observation group than in the control group(P < 0.05).7.Incidence of adverse effects: during the treatment period,nausea(1 patient)occurred in the observation group and nausea(2 patients)and dizziness(1 patient)occurred in the control group.The adverse effects of the above four patients were mild without intervention.The incidence of adverse effects in the observation group and the control group was 3.0%,9.1%,respectively.There was no significant difference between the two groups(P > 0.05).8.Safety aspects: the relevant safety indicators before and after treatment in the two groups of patients showed no obvious abnormalities,and the safety of the treatment regimen in the two groups was good.Conclusion:1.The efficacy of Xingyang Yiwei decoction combined with bismuth quadruple therapy for the treatment of Hp Positive Peptic Ulcer(spleen deficiency damp-heat syndrome)is exact,and it is superior to western medicine alone not only in terms of syndrome efficacy and gastroscopic efficacy,but also in terms of overall symptom improvement and single symptom improvement of epigastric pain,epigastric distension,limb burnout,less sloughing speech,mouth ache or mucus and short and yellow stools.2.There were no significant differences between the two treatment regimens in the rate of HP eradication,the incidence of adverse effects,or the single symptomatic improvement in asthenia.3.This study can enrich the traditional Chinese and Western Medicine(TCM)treatment options for peptic ulcer,which can provide data support for the subsequent clinical use and promotion of Shengyang Yiwei decoction. |